Surgical Ventricular Restoration Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the “Company”), unless otherwise provided in the applicable contract. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. Services Are Considered Investigational Coverage is not available for investigational medical treatments or procedures, drugs, devices or biological products. Based on review of available data the Company considers surgical ventricular restoration (SVR) for the treatment of ischemic dilated cardiomyopathy to be investigational.* Policy Guidelines Surgical ventricular restoration involves increased physician work compared with standard ventriculectomy. For example, the procedure includes evaluation of the ventricular septum and reshaping of the geometry of the heart. Surgical ventricular restoration is described as a global treatment of left ventricular failure, while conventional left ventricular aneurysmectomy represents a local treatment of a transmural infarct. Background/Overview Surgical ventricular restoration is also known as surgical anterior ventricular endocardial restoration, left ventricular reconstructive surgery, endoventricular circular plasty, or the Dor procedure. Named after the surgeon who pioneered the expansion of techniques for ventricular reconstruction and is credited with treating heart failure patients with SVR and coronary artery bypass grafting. SVR is usually performed after coronary artery bypass grafting and may precede or be followed by mitral valve repair or replacement and other procedures such as endocardectomy and cryoablation for treatment of ventricular tachycardia. A key difference between SVR and ventriculectomy (ie, for aneurysm removal) is that, in SVR, circular “purse string” suturing is used around the border of the aneurysmal scar tissue. Tightening of this suture is believed to isolate the akinetic or dyskinetic scar, bring the healthy portion of the ventricular walls together, and restore a more normal ventricular contour. If the defect is large (ie, an opening >3 cm), the ventricle may also be reconstructed using ©2021 Blue Cross and Blue Shield of Louisiana Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana. Page 1 of 9 Surgical Ventricular Restoration Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 patches of autologous or artificial material to maintain the desired ventricular volume and contour during closure of the ventriculotomy. In addition, SVR is distinct from partial left ventriculectomy which does not attempt specifically to resect akinetic segments and restore ventricular contour. FDA or Other Governmental Regulatory Approval U.S. Food and Drug Administration (FDA) The U.S. FDA regulates the marketing of devices used as intracardiac patches through the 510(k) clearance process. These devices are Class II and are identified as polypropylene, polyethylene terephthalate, or polytetrafluoroethylene patch or pledget placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. Biological tissue may also be a component of the patches. In 2004, the CorRestore™ ‡ Patch System (Somanetics; acquired by Medtronic) was cleared for marketing by the FDA for use “as an intracardiac patch for cardiac reconstruction and repair.” The device consists of an oval tissue patch made from glutaraldehyde- fixed bovine pericardium. It is identical to other marketed bovine pericardial patches, except that it incorporates an integral suture bolster in the shape of a ring that is used along with ventricular sizing devices to restore the normal ventricular contour. FDA product code: DXZ. In 2020, Ancora Heart announced that it received an FDA investigational device exemption for its AccuCinch®‡ ventricular restoration system. This exemption allows Ancora Heart to proceed with an initial efficacy and safety study in patients with heart failure and reduced ejection fraction. Rationale/Source Surgical ventricular restoration is designed to restore or remodel the left ventricle to its normal, spherical shape and size in patients with akinetic segments of the heart, secondary to ischemic dilated cardiomyopathy. For individuals who have ischemic dilated cardiomyopathy who receive SVR as an adjunct to coronary artery bypass grafting, the evidence includes a large randomized controlled trial (another randomized controlled trial reported results, but most trial enrollees overlapped with those in the larger trial) and uncontrolled studies. The relevant outcomes are overall survival, symptoms, quality of life, hospitalizations, resource utilization, and treatment-related morbidity. The randomized controlled trial, the Surgical Treatment of Ischemic Heart Failure trial, did not report significant improvements in quality of life outcomes for patients undergoing SVR as an adjunct to standard ©2021 Blue Cross and Blue Shield of Louisiana Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana. Page 2 of 9 Surgical Ventricular Restoration Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 coronary artery bypass grafting surgery. Several uncontrolled studies have suggested that SVR can improve hemodynamic functioning in selected patients with ischemic cardiomyopathy; however, these studies are considered lower quality evidence. The evidence is insufficient to determine the effects of the technology on health outcomes. Supplemental Information Practice Guidelines and Position Statement The purpose of the Supplemental Information is to provide reference material regarding clinical input, existing practice guidelines and position statements, U.S. Preventive Services Task Force Recommendations and Medicare National Coverage Decisions and registered, ongoing clinical trials. Inclusion in the Supplemental Information does not imply endorsement or that the information is used in the evidence review. Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest. European Society of Cardiology and European Association for Cardio-Thoracic Surgery The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (2018; update in progress) developed joint guidelines on myocardial revascularization. The guidelines indicate that surgical ventricular restoration during coronary artery bypass grafting may be considered in selected patients treated in centers with the requisite expertise. U.S. Preventive Services Task Force Recommendations Not applicable. Medicare National Coverage There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers. Ongoing and Unpublished Clinical Trials Some currently ongoing trials that might influence this review are listed in Table 1. ©2021 Blue Cross and Blue Shield of Louisiana Blue Cross and Blue Shield of Louisiana is an independent licensee of the Blue Cross and Blue Shield Association and incorporated as Louisiana Health Service & Indemnity Company. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from Blue Cross and Blue Shield of Louisiana. Page 3 of 9 Surgical Ventricular Restoration Policy # 00184 Original Effective Date: 01/26/2006 Current Effective Date: 06/14/2021 Table 1. Summary of Key Trials Planned Completion NCT No. Trial Name Enrollment Date Ongoing Assessment of Risks and Outcomes of Surgical Intervention in Patients with Ischemic Cardiomyopathy NCT04489355 260 May 2024 in the Early and Long-Term Postoperative Period, Selection of Optimal Surgical Treatment Randomized Clinical Evaluation of the AccuCinch®‡ Ventricular Restoration System in Patients Who Present NCT04331769 400 Mar 2029 With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study References 1. Blue Cross and Blue Shield Association, Medical Policy Reference Manual, “Surgical Ventricular Restoration”, 7.01.103, March 2021. 2. Jones RH, Velazquez EJ, Michler RE, et al. Coronary bypass surgery with or without surgical